FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’

By Lizzy Lawrence

Sept. 19, 2024

FDA Reporter

Check out STAT’s exclusive breakthrough devices tracker. 

The latest medical devices to receive breakthrough status from the Food and Drug Administration range across conditions, with several treating cardio and neurovascular conditions. 

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The FDA’s breakthrough devices program is designed to speed the path to market for novel, potentially lifesaving products. It gives manufacturers better access to regulators and the ability to design more flexible clinical trials. All manufacturers have to do is prove to the FDA that their product may someday “more effectively” treat or diagnose a debilitating disease. 

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   Lizzy Lawrence

   FDA Reporter

   Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter.

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